Having a robust device master record is not optional.
If you climb into FDA’s sandbox, be prepared to play by the rules.
A twist on the classic holiday song, complete with FDA condemnation.
FDA takes control of non-conforming product seriously.
A monumental screw up, complete with bad quality, regulatory and statutory practices.
FDA recently ordered a manufacturer of automated endoscope reprocessors to recall product following a consent decree from 2007.
You need a management representative with oversight over medical device quality.
Perhaps the organizational soul searching should begin after receiving one Form 483.
If you haven’t made the connection yet, you’re in trouble.
It’s never too late to work towards compliance, and quick.